The following data is part of a premarket notification filed by Mark One Healthcare Products with the FDA for Masterhinge.
| Device ID | K833084 |
| 510k Number | K833084 |
| Device Name: | MASTERHINGE |
| Classification | Component, Cast |
| Applicant | MARK ONE HEALTHCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LGF |
| CFR Regulation Number | 888.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-13 |
| Decision Date | 1983-10-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MASTERHINGE 73453292 1349106 Dead/Cancelled |
MARK ONE HEALTHCARE PRODUCTS INC. 1983-11-17 |